May 25, 2017  |  Posted by: 

Leveraging Technology to Address the ALARP vs AFAP Challenge

It is a regulatory requirement for Medical Device companies to perform Risk Management and provide documented evidence to demonstrate compliance with regulation and a company’s own Quality Management System (i.e., Policy & Standard Operating Procedures). Expectations are stipulated in ISO 14971: Medical devices – Application of Read more »

May 05, 2017  |  Posted by: 

In the pharmaceutical, biotechnology and medical device industry equipment validation traditionally is a manual inefficient paper-based process that is plagued with bottle necks and high cost. The inefficiencies found in traditional equipment validation are related to manual activities such as routing documents for review, approval, printing, scanning, storing and archiving paper-based equipment validation documents. There is a significant amount of chal...  
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Apr 28, 2017  |  Posted by: 

A Different Way of Thinking to Improve Validation!

Traditionally, Validation focuses validating something (i.e., an Entity), such as equipment, a computer system, a process, etc. A lot of paper is generated (e.g., VP, IQ, OQ, PQ, RTM). Then the validation package is filed away, typically only pulled during an audit.
The problem is that the same things are continually recreated. Inconsistencies arise, and valuable information is los...  
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Apr 05, 2017  |  Posted by: 

In the life science industry computer validation is typically a manual paper-based process that is plagued with inefficiencies and high cost. The inefficiencies are related to manual activities such as printing and scanning computer validation documents. There is a significant amount of challenges and risk related to paper-based computer validation such as the compliance risk associated to paper. The compliance risk related to paper-based validation ...  
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Mar 21, 2017  |  Posted by: 

Paperless Validation Paperless validation systems were introduced to the industry 10 years ago. Early in the lifecycle of these technology paperless validation system provided standard document management and electronic execution capabilities. This basic funct...  
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Mar 13, 2017  |  Posted by: 

Data Integrity by Design is Your First Line of Defense!

If you’ve had your finger anywhere near the regulatory pulse, then you know Data Integrity is on the regulatory radar. Some turn to statistics to assess data to identify anomalies. Others rely on Validation to ensure a system is performing as intended. Consider the following illustration that identifies three (3) major aspects of the Data Integrity paradigm.

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Feb 24, 2017  |  Posted by: 

Cleaning Validation Validation and calibration are a global regulatory requirement for the life science industry. Validation is defined by the FDA as a process that is required to establish documented evidence which provides a high degree of assurance that a spec...  
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Feb 16, 2017  |  Posted by: 

Writing requirements using must, shall, should statement qualifiers can significantly help you manage and deliver a system that is compliant, fully functional, and maybe even include some nice-to-haves.

Characteristics of a Good Requirement:

Apparatus used to conduct the required process or test.


But first let’s review what characterizes a good requirement statement. The Institute of Electrical and Electronics Engine...  
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